User Testing of the Evivo Screening Test



Status:Not yet recruiting
Healthy:No
Age Range:Any
Updated:7/28/2018
Start Date:August 2018
End Date:September 2018
Contact:Robin Flannery
Email:rflannery@evolvebiosystems.com
Phone:510-410-9537

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User Testing Protocol to Evaluate Performance of the Evivo Infant Gut Bifidobacterium Screening Test

The study is an evaluation of the Evivo Screening Test's ability to differentiate between
high and low levels of Bifidobacterium in infant stool specimens.

This is a prospective, multi-center clinical study of the Evivo Infant Gut Bifidobacterium
Screening Test ("Evivo Screening Test").

Lower levels of bifidobacteria in the infant gut have been linked to increased incidence of
metabolic and inflammatory disorders. This CLIA Waiver User Testing study is being conducted
to evaluate the performance of the Evivo Infant Gut Bifidobacterium Screening Test, which was
designed to differentiate between high and low levels of Bifidobacterium in infant stool.
This study is intended to confirm the precision of results for this screening test, as well
as its ease of use, in a setting that closely resembles the conditions of intended use,
specifically the circumstances of sample collection, the location of test sites, and the
potential operators.

Inclusion Criteria:

- Infants aged 0-6 months.

- Generally healthy infants.

Exclusion Criteria:

- Infants should not have an acute infection.

- Not intended for use with stool containing meconium.

- Infants with jaundice should not be tested until it has resolved.

- This test should not be used for infants with carbohydrate malabsorption syndrome,
which may present with one or more of the following persistent signs: abnormally
foul-smelling, mucus-containing, and/or green frothy stools.
We found this trial at
6
sites
Gresham, Oregon 97030
Phone: 503-907-2179
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Gresham, OR
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Charleston, South Carolina 29414
Phone: 843-518-5642
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Charleston, SC
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Flushing, New York 11367
Phone: 702-720-7323
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Flushing, NY
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Los Angeles, California 90057
Phone: 310-424-5922
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Los Angeles, CA
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Marietta, Georgia 30060
Phone: 404-454-9715
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Marietta, GA
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630 Fairview Road
Swarthmore, Pennsylvania 19081
Phone: 702-720-7323
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Swarthmore, PA
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